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FDA 510(k)

ADVANTAGE 3D XR

K-Number: K974715 · 1998-07-06

ApplicantGE Medical Systems
Decision Date1998-07-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE 3D XR is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1998-07-06 under 510(k) number K974715. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANTAGE 3D XR?

ADVANTAGE 3D XR is a medical device that received FDA 510(k) clearance on 1998-07-06. The listed applicant is GE Medical Systems. The 510(k) number is K974715.

When did ADVANTAGE 3D XR receive FDA 510(k) clearance?

ADVANTAGE 3D XR received FDA 510(k) clearance on 1998-07-06, under 510(k) number K974715.

Who is the listed applicant for ADVANTAGE 3D XR?

The FDA 510(k) record lists GE Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANTAGE 3D XR?

The FDA product code for ADVANTAGE 3D XR is JAK.

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Other records listing GE Medical Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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